MAUDE Adverse Event Report: K2M, INC. FOUNDATION SCREW; SIZE Ø6.5X40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	801-06540D
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 4 mesa foundation screws broke and the inner collets got "stuck into the rod" intra-operatively.Surgery was successfully completed with a 30 minute delay.No adverse consequences or medical intervention were reported.This record will capture the third of four screws.
Additional Manufacturer Narrative
Visual inspection: deformation was observed on the inner collet.Functional inspection: device was able to lock and unlock without issues.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Upon inspection of the returned device, deformation was observed on the inner collet, indicating issues during locking/unlocking.It was communicated by the initial reporter that a mesa rod unlocker, instead of a mesa rail unlocker, was used.It is likely that the use of a mesa rod unlocker on a rail created misalignment on the screw head during unlocking and excess loading, resulting in the observed deformation.The cause of the reported issue will be classified as 'deviation from surgical technique'.
Event or Problem Description
It was reported that 4 mesa foundation screws broke and the inner collets got "stuck into the rod" intra-operatively.Surgery was successfully completed with a 30 minute delay.No adverse consequences or medical intervention were reported.This record will capture the third of four screws.

• Brand Name: FOUNDATION SCREW; SIZE Ø6.5X40 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12478048
• Report Number: 3004774118-2021-00277
• Device Sequence Number: 11707152
• Product Code: NKB
• UDI-Device Identifier: 10888857136120
• UDI-Public: 10888857136120
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 801-06540D
• Device Catalogue Number: 801-06540D
• Device Lot Number: GXXL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown